TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > News & Events > Blog > Proposed delayed commencement of certain Medical Device Regulatory Changes

Proposed delayed commencement of certain Medical Device Regulatory Changes

Time for Change

Author: Jean Boudaud

During recent months, the world has been focusing on their emergency response to the Covid-19 pandemic, while Manufacturers were still expected to implement transitional arrangements to the new Medical Device and In-Vitro Diagnosis Regulations released globally.

Australia is no exception to the rule and a number of regulatory changes described in the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 were initially planned to come into effect between January and August of this rather eventful year…

On 16 June 2020, the TGA announced a proposed delay in the implementation of the reforms up to November 2021. This delay would provide a well justified relief for industry, healthcare professionals and the TGA.

Make sure you keep track of the main changes and their implementation dates:

Reclassification of devices

A good place to start is to discuss device re-classifications. Medical Device Regulations and Regulatory oversight (i.e. Conformity Assessment Procedures) are based on the classification of a device according to the risk associated with its use. A change in your device classification can therefore have a significant impact on your marketing plans and on the expected technical data (e.g. clinical evidence requirements).

The following devices are being up-classified:

  • Spinal Implantable Medical Devices (some will move from Class IIb to Class III)
  • Active Medical Devices for therapy with diagnostic function (from Class IIa/b to Class III)
  • Active Implantables (from AIMD to Class III)
  • Devices administering a medicine or biological by inhalation (From Class I/IIa to IIa/b)
  • Medical Devices that consist of substances introduced into the body via a body orifice or applied to the skin (from Class I/IIa, now up to Class III)
  • Medical Devices in direct contact with the heart, central circulatory or central nervous system (Class IIa to Class III)

This up-classification, which was to come into effect on the 25 August 2020, is now proposed to be delayed until 25 November 2021.

Devices already on the ARTG or for which an application is made prior to the deadline may qualify for special transitional arrangements until 2024.

Software as Medical Devices (SaMDs)

Advancements and widespread software technologies are being progressively accommodated by Regulators around the world. Most notably was in 2017 within the new EU MDR (2017/745) which provided more relevant (i.e. non-physical) classification rules and pathways for Medical Device Software in Europe.

This has now been accommodated in the TGA Regulations and we provided an overview of local applications in our May 2020 blog.

Whilst both the EU and AU follow the broader recommendations set by IMDRF, there are some differences in local applications between the two regions. In March 2020, the TGA also published some additional guidance on legislated definitions that appear in their Regulation.

As per the current amendments, new applications for ARTG inclusions of SaMD would need to follow the new ruling from 25 August 2020. TGA has however, now proposed a new transition date of 25 February 2021. Transitional provisions are also in place for legacy devices.

Personalised Medical Devices

When commercially available mass-produced medical devices are unable to meet the needs of certain clinical cases, healthcare providers may produce or provide specifications to a manufacturer to make, personalised or custom-made devices.

As there are significant differences in the way custom-made medical devices are regulated in comparison to other medical devices and as new technologies become available (e.g. additive manufacturing), there was an increasing risk that a range of distributed medical devices do not fit in the existing regulatory framework.

New reforms have been a couple of years in the making, with the introduction of a new “notification scheme” in 2016, formal requests for information (refer our July 2017 blog) in 2017 and a range of consultations through to 2019.

Regulatory changes are now being formally introduced, these include:

  • Clarification of definitions, which in most cases will result in a narrower scope of exemption from ARTG entry for devices which were previously deemed “custom-made”
  • Changes in requirements for “custom-made” devices, including:
    1. New annual reporting requirements to the TGA for supplied custom devices;
    2. Possible TGA inspections of the custom-device production facilities (regardless of the exemptions, this is another good reason for implementing a good QMS);
    3. Specific record retention periods of at least five years for non-implantable and 15 years for implantable custom-devices; and
    4. Provision of information about the custom device to the intended recipient.

Also worth noting are:

  • new concepts and frameworks for “Medical Device Production Systems” which are essentially the manufacturing tools that produce custom devices (e.g. 3D printer) and which may now become regulated Medical Devices in their own right; and
  • an update to Classification rule 5.4 (X-Ray films and panels) under which Anatomical models and other equivalent “imaging mechanisms” will now be classified as a Medical Device Class IIa (typically a bump from Class I) and subject to the relevant conformity assessment procedure.

Whilst current amendments indicate a transition date of 25 August 2020, the new proposed implementation date is set for 25 February 2021. There are also some transitional arrangements for devices which may be subject to a re-classification.

IVD Companion Diagnostics

Following TGA consultations through 2018-2019, the amended regulations now include new definitions for “IVD companion diagnostic”. The definition provides closer alignment with other major jurisdictions such as the EU and US:

“IVD companion diagnostic means an IVD medical device:
(a) that is intended by the manufacturer to be used for the examination of a specimen from the body of an individual:

  • to identify whether the individual would be likely to benefit from the use of a particular medicine or biological; or
  • to identify whether the individual is likely to be at particular risk of a serious adverse reaction to the use of a particular medicine or biological; or
  • to monitor the individual’s response to the use of a particular medicine or biological; and

(b) that is mentioned in product information for the medicine or biological as being essential for the safe and effective use of the medicine or biological; and

(c) if the medicine or biological comprises blood, a blood component, cells, tissue or an organ, from a donor other than the individual—that is not intended by the manufacturer to be used for the examination of the specimen merely to determine whether the medicine or biological is compatible with the individual.”

Since 1 February 2020, applications for inclusion of an IVD companion diagnostic in the ARTG are subject to a mandatory application audit under amendments at subparagraph 5.3(1)(j)(x).

A TGA Guidance on Regulatory Requirements was published in February 2020 to provide additional information to manufacturer on classifications, IFUs, conformity assessment procedures and most importantly transitional arrangements for applications made before the cut-off date or devices already included on the ARTG.

Further information about the reforms will continue to be published, with the TGA working closely with stakeholders to identify opportunities for continued consultation on guidance material over the coming months. Keep an eye on our blogs and webinars for any relevant updates!

We tailor our services to the requirements of your business and can help you implement plans that are best suited to your projects. 

Contact us
Related posts
Sponsors gear up for a smoother process with CTIS but must first overcome key hurdles
Sponsors gear up for a smoother process with CTIS but must first overcome key hurdles
2nd June 2022
Medical device software brings new complications around compliance
Medical device software brings new complications around compliance
30th May 2022
Is quality documentation an asset or a burden in regulatory affairs?
Is quality documentation an asset or a burden in regulatory affairs?
6th April 2022
Navigating the impact of the IVDR on marketed products
Navigating the impact of the IVDR on marketed products
24th March 2022
Minimizing risk during the transport of medicinal products
Minimizing risk during the transport of medicinal products
21st March 2022
Next Steps for EUDAMED implementation within MDR
Next Steps for EUDAMED implementation within MDR
7th March 2022
Recent Blogs
  • Sponsors gear up for a smoother process with CTIS but must first overcome key hurdles
    2nd June 2022
  • Medical device software brings new complications around compliance
    30th May 2022
  • Is quality documentation an asset or a burden in regulatory affairs?
    6th April 2022
  • Navigating the impact of the IVDR on marketed products
    24th March 2022
  • Minimizing risk during the transport of medicinal products
    21st March 2022
  • Next Steps for EUDAMED implementation within MDR
    7th March 2022
Recent News
  • Why collaboration and an Integrated Product Development program are key to successful drug development
    14th June 2022
  • Key Takeaways from the PDA Europe Annex 1 Workshop
    7th June 2022
  • Addressing Limitations of Sterility Testing
    9th May 2022
  • Are virtual audits sustainable post-pandemic?
    6th May 2022
  • Orphan Drug Designation: Securing the Significant Benefits
    28th March 2022
  • PharmaLex expands pricing & reimbursement and health economics platform with EBMA Consulting merger
    9th March 2022
Upcoming Webinars

July 28th, 2022

The regulatory and business importance of medical device post-market surveillance

09:00 AM CET

Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
30 Jun

The #CTIS brings many opportunities, but it will also require a lot of process changes and preparation, find out more 👉https://lnkd.in/eZRqyPPX about the benefits and challenges with the CTIS.

➡  Take the @Phlexglobal #survey! https://lnkd.in/eA5FwHJC

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Hard working and there when you need them

    Europe based large biotech
    Regulatory Manager
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.






    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for